Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)

Launched by TRANSVERSE MEDICAL, INC. · Apr 29, 2025

Keywords

ClinConnect Summary

The GUARDIAN trial is studying a new device called the Point-Guard, which is designed to help protect patients during a procedure known as Transcatheter Aortic Valve Replacement (TAVR). This procedure is used for people who have a narrowing of the aortic valve, a condition called aortic valve stenosis. The goal of the trial is to see if the Point-Guard device is safe and effective for use during TAVR, helping to ensure that the procedure goes smoothly.

To participate in the trial, patients need to be at least 18 years old and be eligible for a TAVR procedure. They should also be willing to attend follow-up appointments after the procedure. However, some patients may not be eligible, such as those who have certain heart conditions, are pregnant, or have had recent heart surgeries. If enrolled, participants can expect close monitoring during and after their procedure to assess how well the device works. This study is currently recruiting participants and aims to gather important information about the Point-Guard's design and functionality.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. The patient is ≥18 years of age;
• • 2. The patient meets indications for Transcatheter Aortic Valve Replacement (TAVR);
• • 3. The patient is willing to comply with protocol-specified follow-up evaluations;
• • 4. The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board or Ethics Committee.
• Exclusion Criteria:
• • 1. TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
• • 2. Anatomy that precludes safe delivery and retrieval of the investigational device.
• • 3. Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
• • 4. Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
• • 5. Patients with uncontrolled bleeding disorders.
• • 6. Patients who are pregnant, as confirmed by a positive pregnancy test.
• • General Exclusion Criteria
• • 1. TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
• • 2. Anatomy that precludes safe delivery and retrieval of the investigational device.
• • 3. Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
• • 4. Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
• • 5. Patients with uncontrolled bleeding disorders.
• • 5. Patients who are pregnant, as confirmed by a positive pregnancy test.
• Magnetic resonance imaging exclusion criteria:
• • 1. Body Mass Index (BMI) and/or total body weight precluding imaging in scanner.
• • 2. Contraindications to MRI (subjects with any implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).
• • 3. High risk of complete AV block after TAVR, with the need of permanent pacemaker (e.g., subjects with pre-existing bifascicular block or complete right bundle branch block plus any degree of AV block).
• • 4. Existing or planned implantation of a pacemaker or defibrillator implantation within the first 3 days after TAVR.
• • 5. Claustrophobia precluding MRI scanning.